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Completed

NCT Number: NCT06144372

Extracorporeal Shockwave Lithotripsy, Electroconductive and Electrohydraulic Types

To evaluate the efficacy and safety of electroconductive (EC) and electrohydraulic (EH) extracorporeal shock wave lithotripsy (ESWL) for the treatment of ureter and kidney stones, this study conducted a randomized controlled trial.

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Key information

Conditions

Urolithiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The analysis included cases of stones in the upper kidney and ureter, with diameters ranging from 5 mm to 15 mm.

Exclusion criteria

  • Patients with musculoskeletal deformities, ongoing urinary tract infections requiring prioritized infection treatment, blood clotting disorders, and ureteral obstruction that made stone expulsion difficult were excluded from the study.

Treatment and study plan

Electroconductive and Electrohydraulic types

Device

The patients were randomly assigned to two types of lithotripter.

Primary outcomes

  1. age

    Time frame: 2 weeks

    patient's records

  2. Gender

    Time frame: 2 weeks

    patient's records

  3. height

    Time frame: 2 weeks

    meters

  4. weight

    Time frame: 2 weeks

    kilograms

  5. smoking

    Time frame: 2 weeks

    patient's records

  6. drinking

    Time frame: 2 weeks

    patient's records

  7. Diabetes mellitus

    Time frame: 2 weeks

    patient's records

  8. Hypertension

    Time frame: 2 weeks

    patient's records

  9. Preoperative Double J stent

    Time frame: 2 weeks

    patient's records

  10. creatinine

    Time frame: 2 weeks

    patient's records

  11. Glomerular Filtration Rate

    Time frame: 2 weeks

    patient's records

  12. hemoglobin

    Time frame: 2 weeks

    patient's records

  13. Hydronephrosis grade

    Time frame: 2 weeks

    • Grade 0 : Normal examination with no dilation of the renal pelvis
    • Grade 1 : Mild dilation of the renal pelvis only
    • Grade II : Moderate dilation of the renal pelvis including a few calyces
    • Grade III : Dilation of the renal pelvis with visualization of all the calyces, which are uniformly dilated, and normal renal parenchyma
    • Grade IV : Similar apperance of the renal pelvis and calyces as Grade III, plus thinning of the renal parenchyma

  14. Analgesic

    Time frame: 2 weeks

    patient's records

  15. stone size

    Time frame: 2 weeks

    patient's records

  16. Stone laterality

    Time frame: 2 weeks

    patient's records

  17. Stone location

    Time frame: 2 weeks

    patient's records

  18. Stone volume

    Time frame: 2 weeks

    patient's records

  19. Stone shape

    Time frame: 2 weeks

    patient's records

  20. Stone to skin distance

    Time frame: 2 weeks

    patient's records

  21. Hounsfield unit

    Time frame: 2 weeks

    patient's records

  22. Urine color

    Time frame: 2 weeks

    patient's records

  23. Urine Turbidity

    Time frame: 2 weeks

    patient's records

  24. Urine Specific Gravity

    Time frame: 2 weeks

    patient's records

  25. Urine pH

    Time frame: 2 weeks

    patient's records

  26. Intensity

    Time frame: 2 weeks

    ESWL

  27. Used power

    Time frame: 2 weeks

    ESWL

  28. Shock

    Time frame: 2 weeks

    ESWL

  29. Speed

    Time frame: 2 weeks

    ESWL

  30. Visual analog scale for pain

    Time frame: 2 weeks

    0: Represents "No sensation" or "Not at all." 1-3: Indicates a very mild sensation or a low level of the experience, signifying almost no problem.

    4-6: Represents a moderate level, suggesting a moderate presence of the experience or issue.

    7-9: Reflects a high or severe level, signifying a significant presence or seriousness of the problem.

    10: Represents "Maximal sensation" or "Extremely intense" and indicates an extreme presence or severity of the experience or issue.

  31. Satisfaction score

    Time frame: 2 weeks

    • Not satisfied at all.
    • Very low satisfaction.
    • Moderate satisfaction.
    • High satisfaction.
    • Very high or maximum satisfaction.

  32. Stone-free rates (%)

    Time frame: 2 weeks

    ESWL

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Comparison of Efficacy and Safety of Extracorporeal Shockwave Lithotripsy: A Randomized, Controlled Trial Study of Electroconductive and Electrohydraulic Types

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2023
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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